Sanofi is seeking a licence for Lyxumia for adults with type 2 diabetes to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these together with diet and exercise, do not provide adequate glycaemic control.

The company said full European Commission approval for Lyxumia, which typically follows a positive opinion within two or three months, will herald a major expansion of its diabetes franchise in 2013.

Pierre Chancel, senior VP, global diabetes at Sanofi, said: “The CHMP positive opinion for Lyxumia marks an important milestone in the development of this compound and brings us one step closer to serving even more patients by expanding the Sanofi Diabetes product portfolio.”

Although its most common side effects are nausea, vomiting and diarrhoea, there is also a limited risk of hypoglycaemia, and as part of the recommended marketing authorisation Sanofi will have to implement a pharmacovigilance plan for Lyxumia.

Zaltrap recommended for European approval

Sanofi's other new drug to be recommended for European approval at the November CHMP meeting was Zaltrap, an angiogenesis inhibitor that inhibits the blood supply to tumours and was approved in the US in August.

The drug has been submitted for approval in combination with the irinotecan/5 fluorouracil/folinic acid (FOLFIRI) chemotherapy regime to treat adults with metastatic colorectal cancer (MCRC) that is resistant to or has progressed after an oxaliplatin containing regimen.

The CHMP proposes that Zaltrap be prescribed by physicians experienced in the use of antineoplastic medicinal products and, like Lyxumia, wants a pharmacovigilance plan to be implemented as part of the drug's marketing authorisation.

Analysts have predicted modest sales as a second-line therapy for colorectal cancer – in the region of $200m to $300m a year – but with the potential for significant upside if Zaltrap also proves its worth as a first-line treatment and in other cancers.

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